Recommendations for Regulating Software-Based Medical Treatments: Learning from Therapies for Psychiatric Conditions

Theodore T. Lee


Mobile apps and software that claim to treat a diverse set of conditions (including bipolar disorder, depression, and autism) are becoming increasingly popular for their low cost and convenience. While most of these products lack evidence demonstrating their safety or clinical benefits, some developers are submitting clinical studies to the Food and Drug Administration (FDA) in a bid to receive permission to market their products. Some of these efforts have been successful: in September 2017, FDA cleared a mobile medical application for the treatment of substance use disorders, making it the first software-only device that claims to treat a disease to receive FDA marketing permission. This article engages with the question of how FDA should regulate software that claims to treat a disease or condition. The article begins by describing an emerging class of medical devices consisting of mobile apps and other software to treat psychiatric disorders and behavioral or neurodevelopmental conditions (“digital psychiatric therapies”). Digital psychiatric therapies, focused on a subset of conditions, represent the vanguard of the growing trend of “software treatments”— mobile and software applications intended to treat a broad range of diseases and conditions directly. These new technologies raise concerns about safety and effectiveness that the current regulatory framework and pattern of FDA enforcement fails to address systematically. To ensure developer production of clinical studies, this article recommends FDA actively oversee digital psychiatric therapies and other software treatments by setting rigorous safety and effectiveness standards and consistently enforcing them.